News & Analysis as of

Department of Health and Human Services (HHS) › Center for Drug Evaluation and Research (CDER) › Pharmaceutical Industry

Venable LLP

CBER Director Resigns from FDA, Commissioner Makary’s Recent Remarks on FDA Staffing Cuts, CBER Hiring Data, and Additional...

Venable LLP on

Through our Venable FDA Pulse series, we report on critical developments within the Food and Drug Administration (FDA or Agency) that may affect the Agency’s structure and stakeholder interactions. ...more

Venable LLP

HHS Finalizes Staffing Cuts, New CDER Director, CDER Hiring Data, and New AI Councils at FDA

Venable LLP on

Through our Venable FDA Pulse series, we report on critical developments within the Food and Drug Administration (FDA or Agency) that may affect the Agency's structure and stakeholder interactions....more

Gardner Law

FDA Layoffs, RFK Jr. at HHS, and What This Means for FDA-Regulated Companies

Gardner Law on

In recent weeks, the FDA has faced significant cuts, including the layoffs of probationary employees. These employees, many of whom had been hired to fill roles left by retirees or to bolster the agency’s staffing during the...more

Stinson - Government Contracting Matters

GAO Reminds Offerors that It’s Important to Substantiate Key Personnel’s Experience

Stinson - Government Contracting Matters on

Putting your best foot, or best personnel, forward seems like “Winning the Contract Award 101.” But a refresher course never hurts. Recently, the Government Accountability Office (GAO) decision in Deloitte Consulting, LLC...more

Alston & Bird

Alston & Bird Healthcare Week in Review

Alston & Bird on

Below is Alston & Bird’s Healthcare Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more

Mintz - Health Care Viewpoints

Biosimilars in the Limelight – A Lot Has Happened Since January 2018

Mintz - Health Care Viewpoints on

A lot has happened since we last addressed new biosimilar developments in January 2018. In the intervening months, there have been many significant developments related to FDA’s implementation of an efficient regulatory...more

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